Manager, Process Excellence
Core
Lead global process governance for clinical supply systems, ensuring compliance, efficiency, and standardization across multiple sites while acting as a business owner for key systems.
Role type
Manager, Process Excellence (Clinical Supply Systems)
Builds
Standardized clinical supply operations and compliant system lifecycles
Domain
Life Sciences / Clinical Supply / Regulated Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP regulations, Computer System Validation, SOP authorship, process mapping, requirement documentation, UAT coordination, project management, cross-functional leadership
Preferred skills
Lean Six Sigma, business analysis, system ownership in regulated environments, Catalent systems (SFX, JDE, TrackWise, SIS/CCS, ValGenesis)
Technologies
SFX, JDE, TrackWise, SIS/CCS, ValGenesis
Responsibilities
Own and maintain global SOPs and process documentation; manage process requirements and user support for clinical supply systems; gather and approve business requirements for system changes; coordinate system testing and validation; provide guidance on process execution and issue resolution; deliver training on new processes and system releases; monitor process metrics and lead continuous improvement initiatives; collaborate with Quality, IT, and Operations to drive harmonization and compliance.
Seniority
Manager, hands-on IC with leadership experience
